title: Lower incidence of macrovascular complications in patients on insulin glargine versus those on basal human insulins: a population-based cohort study in Italy.
abstract: OBJECTIVE
  The aim of this study was to compare the use of insulin glargine and intermediate/long-acting human insulin (HI) in relation to the incidence of complications in diabetic patients.
  
  
  RESULTS
  A population-based cohort study was conducted using administrative data from four local health authorities in the Abruzzo Region (900,000 inhabitants). Diabetic patients without macrovascular diseases and treated with either intermediate/long-acting HI or glargine were followed for 3-years; the incidence of diabetic (macrovascular, microvascular and metabolic) complications was ascertained by hospital discharge claims and estimated using Cox proportional hazard models. Propensity score (PS) matching was also used to adjust for significant differences in the baseline characteristics between the two groups.
  
  
  RESULTS
  Overall, 1921 diabetic patients were included: 744 intermediate/long-acting HI and 1177 glargine users. During the 3-year follow-up, 209 (28.1%) incident events of any diabetic complication occurred in the intermediate/long-acting HI and 159 (13.5%) in the glargine group. After adjustment for covariates, glargine users had an HR (95% CI) of 0.57 (0.44-0.74) for any diabetic complication and HRs of 0.61 (0.44-0.84), 0.58 (0.33-1.04) and 0.35 (0.18-0.70) for macrovascular, microvascular and metabolic complications, respectively, compared to intermediate/long-acting HI users. PS analyses supported these findings.
  
  
  CONCLUSIONS
  The use of glargine is associated with a lower risk of macrovascular complications compared with traditional basal insulins. However, limitations inherent to the study design including the short length of observation and the lack of data on metabolic control or diabetes duration, do not allow us to consider this association as a proof of causality.
authors.affiliation: CIRFF, "Federico II" University of Naples, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Cammarota
authors.affiliation: Department of Preventive Medical Sciences, "Federico II" University of Naples, Italy.
authors.forename: D
authors.initials: D
authors.lastname: Bruzzese
authors.affiliation: SEFAP, Department of Pharmacological Sciences, University of Milan, Italy; Multimedica IRCCS, S.S. Giovanni, Italy.
authors.forename: A L
authors.initials: AL
authors.lastname: Catapano
authors.affiliation: CIRFF, "Federico II" University of Naples, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Citarella
authors.affiliation: CIRFF, "Federico II" University of Naples, Italy.
authors.forename: L
authors.initials: L
authors.lastname: De Luca
authors.affiliation: Section of Hygiene, Epidemiology, Pharmacology and Legal Medicine, University of Chieti, and Regional Health Care Agency of Abruzzo, Italy.
authors.forename: L
authors.initials: L
authors.lastname: Manzoli
authors.affiliation: Department of Clinical and Experimental Medicine, "Federico II" University of Naples, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Masulli
authors.affiliation: CIRFF, "Federico II" University of Naples, Italy.
authors.forename: E
authors.initials: E
authors.lastname: Menditto
authors.affiliation: Clinical Research Centre, "G. D'Annunzio" University Foundation, Chieti, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Mezzetti
authors.affiliation: CIRFF, "Federico II" University of Naples, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Riegler
authors.affiliation: CIRFF, "Federico II" University of Naples, Italy.
authors.forename: D
authors.initials: D
authors.lastname: Putignano
authors.affiliation: SEFAP, Department of Pharmacological Sciences, University of Milan, Italy.
authors.forename: E
authors.initials: E
authors.lastname: Tragni
authors.affiliation: CIRFF, "Federico II" University of Naples, Italy.
authors.forename: E
authors.initials: E
authors.lastname: Novellino
authors.affiliation: Department of Clinical and Experimental Medicine, "Federico II" University of Naples, Italy. Electronic address: riccardi@unina.it.
authors.forename: G
authors.initials: G
authors.lastname: Riccardi
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D048909:Diabetes Complications / Q000453:epidemiology* / Q000517:prevention & control; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D000069036:Insulin Glargine; D049528:Insulin, Long-Acting / Q000627:therapeutic use*; D007558:Italy / Q000453:epidemiology; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D012189:Retrospective Studies; D012307:Risk Factors; D016896:Treatment Outcome
chemical_list: D049528:Insulin, Long-Acting; C484564:insulin, long-acting, human; D000069036:Insulin Glargine
keywords: Administrative data; Basal human insulins; Insulin glargine; Macrovascular complications; Propensity-score matching